Apparatus for sharp implement transfer, counting and temporary disposal or storage

ABSTRACT

The invention relates to a design for the safe handling of sharp implements and is composed of a plastic rectangular box with approximately half of the box top open. Magnets are embedded within to secure the needle mounted in a special slot. A sliding door on the top half holds used sharp implements, suture needles and scalpel blades. The scalpel anchors are similarly embedded and designed to cover the scalpel itself while exposing only the handle.

TECHNICAL FIELD

[0001] The invention relates to an improved design for a container whichis a health care safety product designed to help protect againstaccidental injury during the passage of sharp instruments; i.e., sutureneedles and scalpels within the performance of any surgical procedure.It does not involve direct patient contact.

BACKGROUND OF THE INVENTION

[0002] There are approximately 500,000 to 800,000 needle stick injuriesreported each year regarding healthcare professionals in the UnitedStates. Other than in the patient's room, these accidents occur mostoften in the operating room. As a result of this significant healthhazard, health device manufacturers have developed various productsdesigned to protect healthcare professionals. These items includeretractable syringes, “sharps” containers, syringe covers, syringeguards, etc. While needle sticks associated with syringes account for anestimated 75% of the problem, IT IS estimated that most of the remaining25% are the result of sticks associated with suturing during surgicalprocedures or during the unprotected passing of these sharps. It is thisniche which has not been adequately adressed by suture manufacturers whohave left it up to the discretion of the end user to provide their ownprotection.

[0003] The Occupational Safety & Health Administration (OSHA) indirective #CPL2-2.44D, issued Nov. 5, 1999 mandated a change in theFederal Blood Borne Pathogens Act. They called for a shift in workpractice controls and issued a call for engineering solutions for usewhen sharps are passed from one individual to another. The Act states,“The employer must use engineering and work practice controls toeliminate occupational exposure or reduce it to the lowest feasibleextent.” Further, they specifically called for the elimination of“hand-to-hand” or direct passing of all sharps. The overall goal is toreduce the risk of accidental needle or scalpel injuries during thisprocess. Additionally, they issued four engineering design requirementswhich include:

[0004] (1) A thick safety feature that provides a barrier between thehands and needle after use. The safety feature should allow or requirethe worker's hands to remain behind the needle at all times;

[0005] (2) The safety feature is an integral part of the device and notan accessory;

[0006] (3) The safety feature is in effect before disassembly andremains in effect after disposal to protect users and trash handlers;and

[0007] (4) The safety feature is as simple as possible, requiring littleor no training to use effectively.

[0008] The apparatus of the present invention is designed to meet all ofOSHA's design requirements while remaining user friendly and without theincorporation of new hand movements during an operation. It is compact,hand-held, and functions for both suture needles of all sizes as well asscalpels. Additionally, it functions as a safe return device (i.e.,passing of sharps occurs in two directions). Moreover, it acts as acounting device for needles and also functions as a temporary storageand/or disposable container for used suture needles and scalpels. Knownefforts to date have been focused on prevention of syringe needle stickswith retractable syringes. Simple guard type devices are also availablefor some scalpels. No other multi-functional yet simple device for usewith suture needles and scalpels that also satisfies the new OSHArequirements is known.

[0009] The Prior Art fails to recognize the value in coupling slots foruse with sharp implements which effectively immobilize the sharpimplement for transfer purposes, coupled with a magnetically enhanceddisposal compartment for easy counting and disposal. By using the noveldesign of the present invention, coupled with the new system arrangementof the essential elements of the invention, a more flexibleconfiguration is shown which overcomes the inherent limitations of theteachings of the Prior Art as well as permitting a wider range ofapplications, not permitted with the presently available systems.

SUMMARY OF THE INVENTION

[0010] The invention eliminates many of the inherent limitations of thePrior Art by designing an apparatus which is composed of a rectangularbox of clear plastic with approximately half of the box top open.Magnets are embedded within to secure the needle mounted in a specialslot. A sliding door on the top half holds sharps (i.e. used sutureneedles and scalpel blades). The scalpel anchors are similarly embeddedand designed to cover the scalpel itself while exposing only the handle.In a preferred embodiment, it is designed for single use, althoughreusable versions are contemplated.

[0011] It is an object of this invention to provide an apparatus whichis designed to meet all of OSHA's new regulations, be hand-held andcompact, with dual functions for both suture needles as well asscalpels.

[0012] These and other objects of this invention will be evident whenviewed in light of the drawings, detailed description, and appendedclaims.

BRIEF DESCRIPTION OF THE DRAWINGS

[0013] The invention may take physical form in certain parts andarrangements of parts, a preferred embodiment of which will be describedin detail in the specification and illustrated in the accompanyingdrawings which form a part hereof, and wherein:

[0014]FIG. 1 is a top view of the apparatus comprising this inventionshowing a sliding door in a partially open position;

[0015]FIG. 2 is a side elevational view of the apparatus shown in FIG.1;

[0016]FIG. 3 is a cross-sectional view as may be taken at the line 3-3in FIG. 2;

[0017]FIG. 4 is a top view of the sliding door;

[0018]FIG. 5 is an enlarged cross-sectional view of the door shown inFIG. 4 as taken at the line 5-5 thereof; and

[0019]FIG. 6 is a cross-sectional view taken at the line 6-6 in FIG. 2and showing an alternative configuration for a wall which divides thetwo compartments of the apparatus.

DETAILED DESCRIPTION OF THE INVENTION

[0020] Referring now to the drawings wherein the showings are forpurposes of illustrating the preferred embodiment of the invention onlyand not for purposes of limiting the same, the Figures show theapparatus for sharp implement transfer, counting and temporary disposalor storage of the present invention.

[0021] This device is hand-held and at least partially constructed ofclear plastic with embedded magnets. The chosen material of constructionmust be capable of withstanding a sterilization environment, although inone embodiment, it will only be used once. Traditionally, sutureneedles, scalpels and other sharps are passed “hand-to-hand” or directlyfrom assistant to surgeon. As an example, in the course of an operation,the passing of sharps occurs in the following steps. The assistantremoves the needle from the sterile package and mounts the needle on aneedle holder. The needle is exposed. The assistant then “passes” theneedle and holder to the surgeon using direct, hand-to-hand technique.The surgeon, when completed, then passes the needle back to theassistant. Again, the needle/scalpel remains exposed at all times duringthis process.

[0022] The needle escort provides protection during each step of theabove procedures. First, the assistant uses a needle holder to mount theneedle within the protective escort device. Secondly, the needle escortdevice is passed with the hands behind the needle, as specified in OSHArequirements. The only way for the surgeon to access the needle is witha needle holder, not with the use of hands or fingers. When complete,the surgeon disposes the needle in the top retractably sealable boxwhere the used needle remains until the end of the case, at which timeall needles are easily counted and the entire device is properlydisposed of, in a permanent fashion, in an appropriate permanent sharpsdisposal container. The needle escort is unique in that it incorporatesprotection without being cumbersome. It is lightweight and disposable.It is designed for both forward and backward passing of instruments andeliminates direct hand-to-hand passing and exposure during the aboveprocess.

[0023] As seen in FIGS. 1 and 2, the apparatus 10 comprises atwo-compartment system in which sterilized sharp implements areremovably positionable for suturing use in exposed holding and handlingreceptacle 12 and sharp implements for either storage or subsequentdisposal are placed in sealable disposal and storage compartment 14. Theapparatus has a pair of longitudinal side walls 16, a pair of end walls34,36, a floor 50, and in a preferred embodiment, an inner wall 18 whichseparates the holding and handling receptacle 12 from the disposal andstorage compartment 14.

[0024] As illustrated in FIGS. 1 and 3, the holding and handlingreceptacle 12 comprises a pair of longitudinal side walls 16, floor 50,inner wall 18, which in a preferred embodiment is shared with adjacentdisposal and storage compartment 14, and exterior receptacle end wall36. In one embodiment of the invention end wall 36 is discontinuous atthree locations, although this number could be increased or decreased,and optionally, eliminated. As evidenced in FIG. 1, a pair of slots 44are shown in spaced apart relationship to each other and positionedtoward longitudinal side walls 16. These openings are available forscalpel insertion and holding when passed from a physician's assistantto a physician. In a preferred embodiment, a third opening 52 is presentwhich in cooperation with V-shaped notch 24 in floor 50 facilitateslinkage with suture material, i.e., thread which is held in engagementwith the apparatus 10 through suture card (not shown) which is securedvia opposed rails 26.

[0025] As illustrated in FIGS. 1 and 6, the sealable disposal andstorage compartment 14 comprises a pair of longitudinal side walls 16, afloor 50, an inner wall 18, which in a preferred embodiment is sharedwith adjacent holding and handling receptacle 12, and exteriorcompartment end wall 34. The end wall is slightly lowered in comparisonto side walls 16 to accommodate sliding engagement of a securelyfastenable covering device 20, which for safety purposes, prevents thesharp implement from falling out of the apparatus when it is positionedin a manner other than laying flat on a horizontal surface. In apreferred embodiment, this covering device 20 will be slidablypositionable via grooves 22 inside exterior walls 16 of disposal andstorage compartment 14 and commonly shared interior wall 18. Thelongitudinal side walls 16 preferably have an indentation 28 containedat approximately the mid-point along the length to accommodate holdingthe apparatus between a thumb and a finger of a user.

[0026] In order to securely position the sharp implements and/orneedles, a pair of magnets 46 are securely positioned on floor 50adjacent end wall 36 of holding and handling receptacle 12. Fordisposal, at least one magnet 38 is positioned in disposal and storagecompartment 14 for securing the sharp implements prior to closing of thereceptacle by cover member 20. Optionally, as best illustrated in FIG.4, the covering device will have a pair of laterally extending hooks 30for stop positioning of the cover member 20 against longitudinal sidewalls 16 and a protruding lip 40 along two longitudinal sides and oneinterior side of the cover member for insertion into grooves 22 on theinterior of longitudinal side walls 16 of disposal and holdingcompartment 14. For ease of movement, a plurality of grooves 32 areeither molded as raised edges or cut into cover member 20. In apreferred embodiment, a first raised ridge 42 a as best seen in FIG. 5,is molded into cover member 20 on the under side for ensuring secureengagement with an interior side of lowered end wall 34 of the disposaland holding compartment 14 of cover member 20. Additionally, a secondraised ridge 42 b is shown positioned interiorly of first raised ridge42 a to minimize the possibility of cover member 20 falling to the floorupon lateral peripheral movement by a user effected to opening the covermember.

[0027] As seen in FIG. 3, a pair of openings 44 in exterior receptacleend wall 36 permit insertion of scalpel blades with associated groovedhandles, said handle grooves typically being normal to the longitudinalaxis of the scalpel and dimensioned so as to frictionally fit intoopenings 44 in end wall 36. In one embodiment of this invention, foam orflexible inserts 48 are positioned within opening 44 so as toaccommodate differently sized scalpel handles.

[0028] When the device is being used in association with suturematerials (not shown), typically provided in sterile elongated packagingdimensioned so as to be frictionally positionable within inwardlydirected legs 26 after removal of the packing material, the sterilizedneedle with suture material threadably attached, is positioned using aneedle holder onto magnets 46 with suture material passing through notch24 in floor 50. After the threaded needle has been positioned ontomagnets 46, the needle holder is disengaged from the needle andapparatus 10 held in a forward facing position exposed to the physicianor suture technician. After passing, the needle is reattached to theneedle holder for use by the physician or suture technician to effectthe skin closure. Upon completion of the closure, the needle isdeposited onto magnet 38 in the disposal and holding compartment 14after opening of securedly refastenable lid 20, followed bydisengagement of the needle holder and closure of lid 20.

[0029] While securedly refastenable lid 20 has been described so far asa slidably repositionable device with a ridge which is guided by agroove in the disposal and holding compartment 14, there is no need tolimit it to such. One of the key considerations is the degree ofintegrity of the closure coupled with the magnet which is positionedalong at least a portion of the bottom of the compartment. Alternativelid configurations could include, a hinged arrangement with frictionalsnap fit characteristics. Yet further embodiments, include encasing themagnet into either the floor of the compartments or in separable plasticinserts dimensioned so as to be positionable within either one or bothof the compartments. This is anticipated to be helpful when the deviceis intended for multiple uses, and sterilized multiple times.

[0030] In light of the sterilization requirement, it is important thatany plastic which is employed to manufacture the apparatus be capable ofwithstanding sterilization environments. Typical of sterilizablepolymers would include the following non-limiting examples:poly(meth)acrylics, e.g., poly(meth)acrylic acids and esters thereof,e.g., poly(meth)acrylates, polyamides such as nylon, polyesters andpolyolefins such as polyethylene, including ultra high molecular weightpolyethylene and crosslinked polyethylenes or polypropylene,polyetherimides, acetal copolymers, polyethersulfones,polyarylethersulfones, polysulfones, PPO (polyphenylene oxide &styrene), polystyrenes, polycarbonates, and ABS (acrylonitrile butadienestyrene).

[0031] In order to implement the OSHA directives, it is important thatcover member 20 be transparent or translucent so as to enable countingof the sharps contained within disposal and holding compartment 14.Other structural members of the apparatus need not have either thetransparent or translucent characteristic.

[0032] This invention has been described in detail with reference tospecific embodiments thereof, including the respective best modes forcarrying out each embodiment. It shall be understood that theseillustrations are by way of example and not by way of limitation.

What is claimed is:
 1. An apparatus which comprises: (a) a pair oflongitudinal side walls; (b) a pair of end walls; (c) a base member inconnected relationship with said walls; (d) at least one inner walldefining at least two cavities within said apparatus; (e) at least twoof said at least two cavities further comprising (i) a magnetic holdingmeans in contact with said base member; and (f) a positionable covermeans over at least one of said at least two cavities.
 2. The apparatusof claim 1 wherein said cover means further comprises (a) at least onesecuring means.
 3. The apparatus of claim 2 wherein said securing meanscomprises (a) at least one raised projection on an interior surface ofsaid securing means.
 4. The apparatus of claim 3 wherein said at leastone raised projection is selected from the group consisting of a pimpleand a ridge.
 5. The apparatus of claim 3 wherein said cover meanscomprises (a) two raised projections on an interior surface of saidsecuring means, a first of said raised projections being in frictionalengagement with an interior surface of said cavity when said cover meanscloses said cavity while a second of said raised projections hinderingcomplete removal of said cover means when said cavity is at leastpartially open.
 6. The apparatus of claim 3 wherein said cover meanscomprises (a) a pair of J-shaped hooks for mating engagement with aportion of said longitudinal side walls.
 7. The apparatus of claim 2which further comprises (a) a magnetic holding means in contact withsaid base member in two of said at least two cavities.
 8. The apparatusof claim 7 which further comprises (a) a pair of inwardly facing legs onan exterior side of said base member.
 9. The apparatus of claim 1wherein (a) said base member has at least one opening disposed therein.10. The apparatus of claim 9 wherein (a) said at least one opening is aV-shaped notch.
 11. The apparatus of claim 2 wherein said cover meansfurther comprises (a) a protruding lip on at least three sides of saidcover means.
 12. The apparatus of claim 11 wherein said cover meansfurther comprises (a) at least one movement facilitating means selectedfrom the group consisting of at least one raised ridge or at least onegroove on an exterior side of said cover means.
 13. The apparatus ofclaim 1 wherein (a) said pair of longitudinal side walls is indented inat least one location in said walls.
 14. The apparatus of claim 1wherein (a) at least one of said pair of end walls has at least oneopening disposed therein.
 15. The apparatus of claim 14 wherein (a) atleast one of said pair of end walls has at least two openings disposedtherein.
 16. The apparatus of claim 15 wherein (a) said pair of endwalls has at least three openings disposed therein.
 17. The apparatus ofclaim 14 wherein (a) said at least one opening is at least partiallylined with a foamed polymer.
 18. An apparatus which comprises: (a) apair of longitudinal side walls; (b) a pair of end walls; (c) a basemember in connected relationship with said walls; (d) one inner walldefining two cavities within said apparatus; (e) each of said twocavities further comprising (i) a magnetic holding means in contact withsaid base member; and (f) a positionable cover means over one of saidtwo cavities.
 19. The apparatus of claim 18 wherein said cover meansfurther comprises (a) at least one securing means.
 20. The apparatus ofclaim 19 wherein said securing means comprises (a) at least one raisedprojection on an interior surface of said securing means.
 21. Theapparatus of claim 20 wherein said at least one raised projection isselected from the group consisting of a pimple and a ridge.
 22. Theapparatus of claim 20 wherein said cover means comprises (a) two raisedprojections on an interior surface of said securing means, a first ofsaid raised projections being in frictional engagement with an interiorsurface of said cavity when said cover means closes said cavity while asecond of said raised projections hindering complete removal of saidcover means when said cavity is at least partially open.
 23. Theapparatus of claim 20 wherein said cover means comprises (a) a pair ofoutwardly facing J-shaped hooks for mating engagement with a portion ofsaid longitudinal side walls.
 24. The apparatus of claim 18 whichfurther comprises (a) a pair of inwardly facing legs on an exterior sideof said base member.
 25. The apparatus of claim 18 wherein (a) said basemember has at least one opening disposed therein.
 26. The apparatus ofclaim 25 wherein (a) said at least one opening is a V-shaped notch. 27.The apparatus of claim 19 wherein said cover means further comprises (a)a protruding lip on at least three sides of said cover means.
 28. Theapparatus of claim 27 wherein said cover means further comprises (a) atleast one movement facilitating means selected from the group consistingof at least one raised ridge or at least one groove on an exterior sideof said cover means.
 29. The apparatus of claim 18 wherein (a) said pairof longitudinal side walls is indented in at least one location in saidwalls.
 30. The apparatus of claim 18 wherein (a) one of said pair of endwalls has at least one opening disposed therein.
 31. The apparatus ofclaim 18 wherein (a) one of said pair of end walls has at least twoopenings disposed therein.
 32. The apparatus of claim 18 wherein (a) oneof end walls has at least three openings disposed therein.
 33. Theapparatus of claim 31 wherein (a) at least one of said at least twoopenings is at least partially lined with a foamed polymer.
 34. Theapparatus of claim 33 wherein (a) at least two of said at least twoopenings is at least partially lined with a foamed polymer.